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Behavioural Intervention
Personalized Feedback for Cancer Survivor Physical Activity (Project KNOWN Trial)
N/A
Recruiting
Led By Yue Liao, MPH, PhD
Research Sponsored by The University of Texas at Arlington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18 years or older
Have no current diagnosis or history of type 1 or 2 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 months.
Awards & highlights
Project KNOWN Trial Summary
This trial is looking at how to get cancer survivors who are at high risk for type 2 diabetes to be more physically active using personalized feedback.
Who is the study for?
This trial is for cancer survivors over 18, who've finished treatment at least 3 months ago and are at high risk for type 2 diabetes due to inactivity. Participants must speak English, have a smartphone with internet, and be able to exercise moderately without supervision. Those on certain insulin treatments, other health programs, incompatible smartphones, pregnant women, dialysis patients, overnight workers or those with activity-limiting health issues can't join.Check my eligibility
What is being tested?
The study tests if real-time glucose feedback from wearable devices motivates physical activity in inactive cancer survivors at risk of type 2 diabetes. It compares standard feedback against glucose-based biofeedback using continuous monitors and tracks daily activity levels to see the immediate effects of exercise on biological status.See study design
What are the potential side effects?
Since this trial involves non-invasive monitoring through wearables rather than medication or invasive procedures, significant side effects are not expected. However, participants may experience discomfort or skin irritation from wearing the devices.
Project KNOWN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have never been diagnosed with diabetes.
Select...
I finished my cancer treatment aimed at curing it over 3 months ago, except for hormone therapy or ongoing chemo.
Project KNOWN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 3 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of delivering personalized glucose-based feedback
Secondary outcome measures
Changes in daily physical activity level
Project KNOWN Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Biofeedback GroupExperimental Treatment2 Interventions
Group II: Standard Care GroupActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glucose monitoring
2019
N/A
~10
Find a Location
Who is running the clinical trial?
The University of Texas at ArlingtonLead Sponsor
43 Previous Clinical Trials
4,888 Total Patients Enrolled
American Institute for Cancer ResearchOTHER
10 Previous Clinical Trials
8,511 Total Patients Enrolled
Yue Liao, MPH, PhDPrincipal InvestigatorUniversity of Texas at Arlington
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can do moderate to hard exercise on my own.I do not own a smartphone that works with Fitbit and LibreLink apps.I have never been diagnosed with diabetes.I am currently on dialysis.I am not willing to use the devices required for the study.I am currently taking medication for diabetes in pill form.I have health problems that restrict my physical activity.I am 18 years old or older.I finished my cancer treatment aimed at curing it over 3 months ago, except for hormone therapy or ongoing chemo.I am currently not on any insulin treatment except for basal insulin.I have been diagnosed with cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Biofeedback Group
- Group 2: Standard Care Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available spots for this research project?
"This research is actively seeking participants, as evidenced by the postings of clinicaltrials.gov. The trial was first advertised on January 15th 2023 and has since been updated most recently in October 28th 2022."
Answered by AI
How many participants are being admitted to this trial?
"Affirmative. Details available on clinicaltrials.gov demonstrate that this investigation is proactively searching for participants and has been since January 15th of 2023, with a most recent update taking place on October 28th 2022. The trial seeks to recruit 50 individuals from one location."
Answered by AI
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